Oximio in Serbia: The Gateway to Clinical Trials in Europe and Beyond

In recent years Serbia has emerged as a prominent and enticing destination for clinical trials research. With its flexible approach, enhanced regulations and cost-effectiveness it is able to offer quick, agile solutions for clinical trials and is rapidly becoming a preferred choice for many pharmaceutical and biotech companies over many other European Union (EU) countries.

In this article, Andras Orisek, Managing Director of Oximio in Serbia highlights some of the key factors making Serbia an attractive hub for conducting clinical trials.

Regulatory Approach

Serbia has made significant strides in enhancing its regulatory framework for clinical trials. The pharmaceutical industry is a priority for the government to drive economic growth. It has been proactive in aligning its regulatory procedures with EU standards making it easier for companies to conduct clinical trials within the country ensuring compliance with international requirements. It has also made efforts to simplify bureaucratic procedures for clinical trials which has resulted in shorter timelines for regulatory approvals, minimising delays. Typical clinical trial approval application timelines are 60 days.

Competitive Costs

Serbia offers cost advantages compared to many other EU countries whilst still maintaining high-quality standards. It has one of the lowest labour costs in Europe, investors benefit from generous incentives and free-trade arrangements with EU and other markets. This affordability is a significant attraction for sponsors.

Strategic Location and Diverse Population

Serbia benefits from an excellent, central, European geographic location serving as a crossroads for East and West. With excellent transport links and infrastructure, it is an easily accessible location.

The country has a diverse population of over 7 million people. This offers a valuable advantage for clinical trials as researchers are able to access a wide patient pool covering a range of genetic backgrounds and medical conditions which enhances the representation of their patient studies. The opportunity for patients to take part in a clinical trial means that they can gain access to pharmaceutical products which are limited or may not be available under state-funded programs. These factors have resulted in efficient patient recruitment capabilities reducing the time and resources needed to enrol patients into clinical trials. This is crucial in expediting trial timelines.

Experienced Workforce

Serbia boasts a well-educated and highly trained workforce including clinical research professionals, investigators and site staff. Healthcare providers deliver high quality clinical trial data derived under GxP guidelines and can facilitate reduced study timelines. This expertise, combined with a patient-centric approach, ensures that studies run smoothly adhering to quality international standards.

Oximio’s Clinical Trials Solutions in Serbia

Oximio’s Serbian facility is situated in Belgrade, an excellent gateway to the Balkans, Asia and Western Europe. Supported by a global distribution network, Oximio Serbia, has a worldwide reach.

Boasting an overall storage capacity of 385 m², this includes a customs bonded warehouse. Complete with WDA Licence, the facilities provide increased efficiency, a centralised supply chain governance, and in some instances, cost savings of up to 50% compared to other direct-to-site models.

Following GMP best practice Oximio, Serbia offers end-to-end clinical trial logistic services and competitive, comparator sourcing.

Oximio Serbia at a glance:

Certificates:

• WHL License
• ISO 9001:2015 Certificate
  
  

Storage:

• Overall storage capacity: 385 m2
• Non-Controlled ambient: 82.1 m² (bonded warehouse represents 14.3 m2)
• Ambient: 15⁰C – 25⁰C: 93.8 m² (bonded warehouse represents 14.3 m2)
• Cold Chain: 2⁰C – 8⁰C: 51 m² (bonded warehouse represents 9.5 m²)
• Frozen: -40°C to -20°C: On request
• Ultra-low -80°C to -25°C: On request
• LN2 (Cryogenic): On request
• Office and other non-controlled: 158.1 m²
  
  

Product Types:

• Biological Goods
• Blood Product or Derivative
• Antibiotic
• Cytotoxi
• Controlled Drugs on Request
  
  

For further information on our comprehensive clinical trial logistic services can support your research, please contact us.